II 

114TH CONGRESS 

1ST SESSION S. 1013 

To amend title XVIII of the Social Security Act to provide for coverage 

and payment for complex rehabilitation technology items under the Medicare program, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

APRIL 20, 2015 

Mr. COCHRAN (for himself and Mr. SCHUMER) introduced the following bill; 

which was read twice and referred to the Committee on Finance 

A BILL 

To amend title XVIII of the Social Security Act to provide 

for coverage and payment for complex rehabilitation technology items under the Medicare program, and for other 

purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ensuring Access to 

5 Quality Complex Rehabilitation Technology Act of 2015’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) Individuals with disabilities and significant 

2 medical conditions such as Cerebral Palsy, Muscular 

3 Dystrophy, Multiple Sclerosis, Spinal Cord Injury, 

4 Amyotrophic Lateral Sclerosis, and Spina Bifida ex5 perience physical, functional, and cognitive chal6 lenges every day. 

7 (2) Complex rehabilitation technology items (in 

8 this Act referred to as ‘‘CRT items’’), including 

9 products such as complex rehabilitation power wheel10 chairs, highly configurable manual wheelchairs, 

11 adaptive seating and positioning systems, and other 

12 specialized equipment, such as standing frames and 

13 gait trainers, enable individuals to maximize their 

14 function and minimize the extent and costs of their 

15 medical care. 

16 (3) Access to CRT items and related services 

17 can be threatened by inadequate coding, coverage, 

18 and payment policies for such items and services. 

19 These policies have restricted access to existing com20 plex rehabilitation technology and stifled innovation. 

21 Access challenges have increased over the past sev22 eral years and, without meaningful change to these 

23 policies, will only become greater in the future. 

24 (4) Current Medicare policies often fail to ade25 quately address the needs of individuals with disabilVerDate Sep 11 2014 00:27 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1013.IS S1013

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1 ities, to consider the range of services furnished by 

2 complex rehabilitation technology suppliers, and to 

3 recognize and account for the complexity and unique 

4 nature of the equipment itself. 

5 (5) A significant factor responsible for such ac6 cess challenges is that individually-configurable CRT 

7 items do not have a distinct payment category under 

8 the Medicare program, but instead are classified 

9 within the broad category of durable medical equip10 ment (DME). CRT items serve patients with serious 

11 medical conditions that require a broader range of 

12 services and specialized personnel than what is re13 quired for standard DME. Individually-configured 

14 CRT items also require more resources in the areas 

15 of configuring, training, and education to ensure ap16 propriate use and to optimize results. 

17 (6) Unlike most DME, a medical model incor18 porating an interdisciplinary team approach is nec19 essary to ensure proper individual configuration and 

20 use of a CRT item. This team typically includes a 

21 physician, a licensed physical or licensed occupa22 tional therapist (with no financial relationship with 

23 the CRT supplier), a qualified CRT professional, the 

24 individual using such item, and sometimes a care25 giver for such individual. 


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1 (7) The Medicare program should recognize the 

2 specialized nature of the CRT service delivery model, 

3 the required supporting processes and technology-re4 lated CRT services, the credentials and competencies 

5 needed by the providing suppliers and critical staff, 

6 and the related costs involved. A separate benefit 

7 category for CRT items would allow for unique cod8 ing, coverage, and payment rules and policies that 

9 address the unique needs of persons with disabilities 

10 and acknowledge the extensive service component. 

11 (8) Congress and the Centers for Medicare & 

12 Medicaid Services have previously recognized the 

13 benefits of a separate classification for unique, indi14 vidually-configured products. In 2008, Congress ex15 empted certain CRT items from inclusion in the 

16 Medicare DME competitive bidding program, and 

17 Congress has created a separate and distinct benefit 

18 category for orthotics and prosthetics (custom braces 

19 and artificial limbs), which have their own medical 

20 policies, accreditation standards, and payment cal21 culations. 


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1 SEC. 3. ESTABLISHING SEPARATE BENEFIT CATEGORY FOR 

2 COMPLEX REHABILITATION TECHNOLOGIES 

3 WITHIN MEDICARE. 

4 (a) NEW CATEGORY.—Section 1861 of the Social Se5 curity Act (42 U.S.C. 1395x) is amended— 

6 (1) in subsection (s)(2)— 

7 (A) in subparagraph (EE), by striking 

8 ‘‘and’’ at the end; 

9 (B) in subparagraph (FF), by inserting 

10 ‘‘and’’ at the end; and 

11 (C) by inserting after subparagraph (FF) 

12 the following new paragraph: 

13 ‘‘(GG) complex rehabilitation technology 

14 items (as defined in subsection (iii));’’; and 

15 (2) by adding at the end the following new sub16 section: 

17 ‘‘Complex Rehabilitation Technology Item 

18 ‘‘(iii)(1) The terms ‘complex rehabilitation technology 

19 item’ and ‘CRT item’ mean an item that— 

20 ‘‘(A) is designed or individually configured for 

21 a specific qualified individual to meet the individ22 ual’s unique— 

23 ‘‘(i) medical, physical, or functional needs 

24 related to a medical condition; and 

25 ‘‘(ii) capacities for basic activities of daily 

26 living or instrumental activities of daily living; 


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1 ‘‘(B) is primarily used to serve a medical or 

2 functional purpose and is generally not useful to a 

3 person in the absence of illness or injury; and 

4 ‘‘(C) requires certain services to ensure appro5 priate design, configuration, and use of such item, 

6 including— 

7 ‘‘(i) an evaluation of needs and capacities 

8 and matching of the features and functions of 

9 CRT items to the qualified individual who will 

10 use such an item; and 

11 ‘‘(ii) configuring, fitting, programming, ad12 justing, or adapting the particular complex re13 habilitation technology item for use by such in14 dividual. 

15 ‘‘(2)(A) The Secretary, in consultation with the Di16 rector of Office on Disability, the Chairman of the Na17 tional Council on Disability, the Executive Director on the 

18 Interagency Committee on Disability, the Director of the 

19 National Institute on Disability and Rehabilitation Re20 search of the Department of Education, and the Co-Chair21 men of the Senior Oversight Committee’s Care Manage22 ment Reform Team of the Department of Defense and the 

23 Veterans Administration, shall, by regulation— 

24 ‘‘(i) designate items as complex rehabilitation 

25 technology items; and 


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1 ‘‘(ii) establish eligibility criteria to determine if 

2 an individual is a qualified individual based on the 

3 level of physical and functional needs and capacities 

4 related to a medical condition or conditions de5 scribed in subparagraph (F). 

6 ‘‘(B) The items designated as complex rehabilitation 

7 technology items under subparagraph (A)(i) shall include 

8 items which, as of January 1, 2015 , were classified within 

9 the following HCPCS codes: E0637, E0638, E0641, 

10 E0642, E0986, E1002, E1003, E1004, E1005, E1006, 

11 E1007, E1008, E1009, E1010, E1011, E1014, E1037, 

12 E1161, E1220, E1228, E1229, E1231, E1232, E1233, 

13 E1234, E1235, E1236, E1237, E1238, E1239 E2209, 

14 E2291, E2292, E2293, E2294, E2295, E2300, E2301, 

15 E2310, E2311, E2312, E2313, E2321, E2322, E2323, 

16 E2324, E2325, E2326, E2327, E2328, E2329, E2330, 

17 E2331, E2351, E2373, E2374, E2376, E2377, E2609, 

18 E2610, E2617, E8000, E8001, E8002, K0005, K0835, 

19 K0836, K0837, K0838, K0839, K0840, K0841, K0842, 

20 K0843, K0848, K0849, K0850, K0851, K0852, K0853, 

21 K0854, K0855, K0856, K0857, K0858, K0859, K0860, 

22 K0861, K0862, K0863, K0864, K0868, K0869, K0870, 

23 K0871, K0877, K0878, K0879, K0880, K0884, K0885, 

24 K0886, K0890, K0891, and K0898. 


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1 ‘‘(C)(i) The items designated as complex rehabilita2 tion technology items under subparagraph (A)(i) shall in3 clude each item that— 

4 ‘‘(I) as of January 1, 2015, was classified with5 in the HCPCS codes under clause (ii); and 

6 ‘‘(II) the Secretary, acting in consultation with 

7 suppliers and manufacturers of CRT items, deter8 mines which items should be removed from such 

9 code and assigned a new HCPCS code because such 

10 item is a complex rehabilitation technology item. 

11 ‘‘(ii) The HCPCS codes under this clause are the fol12 lowing: E0143, E0950, E0951, E0952, E0955, E0956, 

13 E0957, E0960, E0967, E0978, E0990, E1015, E1016, 

14 E1028, E01029, E1030, E2205, E2208, E2231, E2368, 

15 E2369, E2370, E2605, E2606, E2607, E2608, E2613, 

16 E2614, E2615, E2616, E2620, E2621, E2624, E2625, 

17 K0004, K0009, K0040, K0108, and K0669. 

18 ‘‘(D) The Secretary may not designate as a complex 

19 rehabilitation technology item— 

20 ‘‘(i) adaptive equipment to operate motor vehi21 cles; 

22 ‘‘(ii) prosthetic devices described in subsection 

23 (s)(8); or 

24 ‘‘(iii) orthotics and prosthetics described in sub25 section (s)(9). 


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1 ‘‘(E) The Secretary shall publish guidelines and im2 plement a process to facilitate the submission of com3 prehensive coding proposals addressing CRT items to be 

4 submitted to the CMS HCPCS Work Group and included 

5 in the HCPCS Work Group public meetings. 

6 ‘‘(F) In establishing the eligibility criteria under sub7 paragraph (A)(ii), the Secretary shall include appropriate 

8 physical and functional needs and capacities arising from 

9 any of the following medical conditions: 

10 ‘‘(i) Congenital disorders, progressive or degen11 erative neuromuscular diseases, or injuries or trau12 ma that result in significant physical or functional 

13 needs and capacities. 

14 ‘‘(ii) Spinal cord injury, traumatic brain injury, 

15 cerebral palsy, muscular dystrophy, spina bifida, 

16 osteogenesis imperfecta, arthrogryposis, amyotrophic 

17 lateral sclerosis, multiple sclerosis, demyelinating 

18 disease, myelopathy, myopathy, progressive muscular 

19 atrophy, anterior horn cell disease, post-polio syn20 drome, cerebellar degeneration, dystonia, Hunting21 ton’s disease, or spinocerebellar disease. 

22 ‘‘(iii) Certain types of amputation, paralysis, or 

23 paresis that result in significant physical or func24 tional needs and capacities. 

25 ‘‘(G)(i) For 2016, the Secretary shall publish— 


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1 ‘‘(I) a list of items designated under subpara2 graph (A)(i) and the HCPCS codes for such items; 

3 and 

4 ‘‘(II) the eligibility criteria established under 

5 subparagraph (A)(ii). 

6 ‘‘(ii) For 2017 and each subsequent year, the Sec7 retary shall publish any necessary updates to such list (in8 cluding additions of new CRT items and any changes in 

9 applicable HCPCS codes) and to such eligibility criteria. 

10 ‘‘(H) The Secretary shall make available, on a public 

11 Web site, the process by which the Secretary will consider 

12 requests from members of the public that the Secretary— 

13 ‘‘(i) designate an item as a CRT item under 

14 subparagraph (A)(i); or 

15 ‘‘(ii) amend the eligibility criteria established 

16 under subparagraph (A)(ii). 

17 ‘‘(3) For purposes of this subsection: 

18 ‘‘(A) The term ‘capacity for basic activities of 

19 daily living’ means an individual’s capacity to safely 

20 participate in mobility and self-care activities includ21 ing— 

22 ‘‘(i) maintaining and changing body posi23 tion; 

24 ‘‘(ii) transferring to or from one surface to 

25 another; 


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1 ‘‘(iii) walking; 

2 ‘‘(iv) moving from place to place using mo3 bility equipment, in a safe and timely manner; 

4 ‘‘(v) washing one’s self; 

5 ‘‘(vi) caring for the body; 

6 ‘‘(vii) toileting; 

7 ‘‘(viii) dressing; 

8 ‘‘(ix) eating; 

9 ‘‘(x) drinking; 

10 ‘‘(xi) looking after one’s health; and 

11 ‘‘(xii) carrying, moving, and handling ob12 jects to perform and participate in other activi13 ties under this subparagraph and subparagraph 

14 (B). 

15 ‘‘(B) The term ‘capacity for instrumental activi16 ties of daily living’ means an individual’s capacity to 

17 safely participate in life situations in the home and 

18 community, including— 

19 ‘‘(i) communicating; 

20 ‘‘(ii) moving around using transportation; 

21 ‘‘(iii) acquiring necessities, goods, and 

22 services; 

23 ‘‘(iv) performing household tasks; 

24 ‘‘(v) caring for household members and 

25 family members; 


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1 ‘‘(vi) caring for household objects; 

2 ‘‘(vii) engaging in education, work, employ3 ment and economic life; and 

4 ‘‘(viii) participating in community, social, 

5 and civic activities. 

6 ‘‘(C) The term ‘HCPCS’ refers to the Health 

7 Care Procedure Coding System. 

8 ‘‘(D) The term ‘individually-configured’ means, 

9 with respect to an item, that— 

10 ‘‘(i) the item has features, adjustments, or 

11 modifications specific to the individual who uses 

12 such item or the item is used in combination 

13 with other CRT items specific to the individ14 ual’s needs; and 

15 ‘‘(ii) the supplier of such item must meas16 ure the individual and configure, fit, program, 

17 adjust, or adapt the item, as appropriate, so 

18 that the item is consistent with— 

19 ‘‘(I) an assessment or evaluation of 

20 the individual by an appropriate licensed 

21 clinician; 

22 ‘‘(II) the written order required under 

23 section 1834(r)(2)(B)(i); and 

24 ‘‘(III) medical condition, physical and 

25 functional needs and capacities, and body 


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1 size of the individual who will use the item, 

2 the period for which such individual will 

3 need such item, and the intended use of 

4 such item by such individual. 

5 ‘‘(E) The term ‘qualified individual’ means an 

6 individual who— 

7 ‘‘(i) is enrolled under part B; and 

8 ‘‘(ii) has physical and functional needs and 

9 capacities that arise from a medical condition 

10 that meet the eligibility criteria established by 

11 the Secretary under paragraph (2)(A)(ii).’’. 

12 SEC. 4. PAYMENT RULES. 

13 Section 1834 of the Social Security Act (42 U.S.C. 

14 1395m) is amended by adding at the end the following: 

15 ‘‘(r) COVERAGE AND PAYMENT FOR CRT ITEMS.— 

16 ‘‘(1) GENERAL RULE FOR PAYMENT.— 

17 ‘‘(A) IN GENERAL.—Not later than the 

18 date that is one year after the date of the en19 actment of this subsection, subject to subpara20 graph (B), the Secretary shall determine a pay21 ment system that shall apply to CRT items— 

22 ‘‘(i) with HCPCS codes that were as23 signed to the item under section 

24 1861(iii)(2)(C)(i)(II); 


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1 ‘‘(ii) for which no HCPCS code was 

2 assigned prior to such date; or 

3 ‘‘(iii) which, prior to such date, was 

4 classified under a miscellaneous HCPCS 

5 code. 

6 ‘‘(B) CONSIDERATIONS.—In determining 

7 the payment system under subparagraph (A), 

8 the Secretary— 

9 ‘‘(i) may disregard the freezes on CPI 

10 increases to the payment amounts for du11 rable medical equipment that occurred be12 fore the date of the enactment of this sub13 section, when determining the payment 

14 amount for CRT items; 

15 ‘‘(ii) shall ensure that the payment 

16 amounts for CRT items under such system 

17 are adequate to provide qualified individ18 uals with access to such items and to en19 courage innovation, taking into account— 

20 ‘‘(I) the unique needs of qualified 

21 individuals for access to CRT items; 

22 ‘‘(II) the unique complexity of 

23 CRT items; and 

24 ‘‘(III) the resources and staff 

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1 vidual configuration of CRT items for 

2 a qualified individual; and 

3 ‘‘(iii) shall provide that CRT codes 

4 will be paid on a purchase basis with a 

5 beneficiary rental basis option. 

6 ‘‘(C) EXCLUSIVE PAYMENT RULE.—This 

7 subsection shall constitute the exclusive provi8 sion of this title for payment for CRT items 

9 under this part or under part A to a home 

10 health agency. 

11 ‘‘(D) LIMITATION ON PAYMENT.—No pay12 ment shall be made under this subsection for a 

13 CRT item unless such CRT item— 

14 ‘‘(i) is provided to a qualified indi15 vidual; 

16 ‘‘(ii) meets the clinical conditions for 

17 coverage established under paragraph (2); 

18 and 

19 ‘‘(iii) is furnished by a supplier ac20 credited pursuant to paragraph (3). 

21 ‘‘(2) CLINICAL CONDITIONS FOR COVERAGE.— 

22 ‘‘(A) IN GENERAL.—The Secretary shall 

23 establish standards for clinical conditions for 

24 payment for CRT items under this subsection. 


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1 ‘‘(B) REQUIREMENTS.—The standards es2 tablished under subparagraph (A) shall require 

3 the following: 

4 ‘‘(i) WRITTEN ORDER.— 

5 ‘‘(I) IN GENERAL.—A qualified 

6 ordering practitioner shall provide a 

7 written order for a CRT item for a 

8 qualified individual before the Sec9 retary may provide payment for such 

10 item for such individual under this 

11 subsection. 

12 ‘‘(II) CRT EVALUATION.—In the 

13 case of a CRT item that is cat14 egorized by the Secretary, for pur15 poses of the program under this title, 

16 as a manual wheelchair or a power 

17 wheelchair, and is to be provided to a 

18 qualified individual who has a diag19 nosis specified under subparagraph 

20 (C), the qualified ordering practitioner 

21 may not provide a written order under 

22 subclause (I) unless the qualified indi23 vidual has undergone a CRT evalua24 tion conducted by a licensed physical 

25 therapist or occupational therapist 


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1 who has no financial relationship with 

2 the CRT supplier. The performance of 

3 such a CRT evaluation by a licensed 

4 physical or occupational therapist 

5 shall not be subject (or counted to6 wards) the limitation on certain ther7 apy services under section 1833(g). 

8 ‘‘(ii) DOCUMENTATION OF MEDICAL

9 NECESSITY.—A qualified ordering practi10 tioner who provides a written order under 

11 clause (i) shall maintain documentation of 

12 the medical necessity of such order for a 

13 period of seven years and shall make such 

14 documentation available to the Secretary 

15 upon request. The documentation of med16 ical necessity under this clause shall in17 clude— 

18 ‘‘(I) evidence that the individual 

19 for whom the order was written has 

20 physical and functional needs and ca21 pacities related to a medical condition 

22 that meet the eligibility criteria estab23 lished under section 

24 1861(iii)(2)(A)(ii); and 


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1 ‘‘(II) evidence of any CRT eval2 uation required under clause (i)(II). 

3 ‘‘(C) SPECIFICATION OF DIAGNOSIS FOR

4 CRT EVALUATION.—The Secretary, in consulta5 tion with relevant parties (including the agen6 cies listed in section 1861(iii)(2)(A), physicians, 

7 licensed physical therapists, licensed occupa8 tional therapists, and suppliers of complex reha9 bilitation technologies) shall specify the diag10 noses and other medical presentations for which 

11 the requirement for a CRT evaluation under 

12 subparagraph (B)(i)(II) shall apply. 

13 ‘‘(D) COVERAGE DETERMINATIONS.—In 

14 developing the standards under subparagraph 

15 (A), the coverage of CRT items with respect to 

16 an individual shall be based on— 

17 ‘‘(i) the specific medical, physical, and 

18 functional needs of the individual; 

19 ‘‘(ii) the individual’s capacities for 

20 safe participation in basic activities of 

21 daily living and instrumental activities of 

22 daily living in all routinely encountered en23 vironments (as such terms are defined in 

24 section 1861(iii)(3)); and 


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1 ‘‘(iii) the individual’s expected pro2 gression of such needs and capacities. 

3 ‘‘(E) CONTRACTOR INDIVIDUALIZED CON4 SIDERATION.—The Secretary shall instruct 

5 Medicare contractors to provide individual con6 sideration in cases that may lack one of the di7 agnoses identified, but that exhibit comparable 

8 functional presentations or deficits (or both) 

9 and where the need for CRT items has been 

10 documented by the qualified clinical profes11 sional. 

12 ‘‘(F) PAYMENT FOR RESIDENTS OF

13 SKILLED NURSING FACILITIES.—In the case of 

14 a qualified individual who is a resident of a 

15 skilled nursing facility, payment may only be 

16 made under this subsection for a CRT item for 

17 such individual if such CRT item is required as 

18 part of a plan of care to allow the transition of 

19 such individual from the skilled nursing facility 

20 to a home or community setting. 

21 ‘‘(3) ESTABLISHMENT OF QUALITY STAND22 ARDS.— 

23 ‘‘(A) ESTABLISHMENT.—The Secretary 

24 shall establish, through regulation, quality 

25 standards for suppliers of CRT items. Such 


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1 standards shall be applied prospectively and 

2 shall be published on the Internet Web site of 

3 the Centers for Medicare and Medicaid Serv4 ices. 

5 ‘‘(B) CONSULTATION.—In establishing the 

6 quality standards under subparagraph (A), the 

7 Secretary shall consult with relevant parties (in8 cluding clinicians, consumer groups, suppliers, 

9 and manufacturers). 

10 ‘‘(C) REQUIREMENTS OF STANDARDS.—In 

11 establishing the quality standards under sub12 paragraph (A), the Secretary shall require that 

13 the suppliers of CRT items meet the following 

14 requirements: 

15 ‘‘(i) DME STANDARDS.—The supplier 

16 complies with all of the standards that are 

17 applicable to suppliers of durable medical 

18 equipment under subsection (a)(20) and 

19 suppliers of medical equipment and sup20 plies under subsection (j). 

21 ‘‘(ii) QUALIFIED CRT PROFES22 SIONAL.—The supplier of a CRT item 

23 makes available, in each service area 

24 served by such supplier, at least one quali25 fied CRT professional to— 


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1 ‘‘(I) analyze the needs and capac2 ities of individuals for a CRT item in 

3 collaboration with the clinical team; 

4 ‘‘(II) assist in selecting an appro5 priate CRT item for such individual, 

6 given such needs and capacities; and 

7 ‘‘(III) provide technology-related 

8 training to such individual in the 

9 proper use and maintenance of the 

10 CRT items. 

11 ‘‘(iii) TRIAL EQUIPMENT.—The sup12 plier of the CRT item provides the quali13 fied individual with appropriate equipment 

14 for trial and simulation, if a physician, li15 censed physical therapist, or licensed occu16 pational therapist determines that the pro17 vision of such equipment is necessary. 

18 ‘‘(iv) INFORMATION ON SERVICE AND

19 REPAIR.—The supplier of the CRT item 

20 provides the qualified individual with writ21 ten information on accessing service and 

22 repair for the CRT item before the CRT 

23 item is ordered for the individual. 

24 ‘‘(v) REPAIR.—The supplier of a CRT 

25 item— 


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1 ‘‘(I) makes available, in each 

2 service area served by such supplier, 

3 at least one qualified CRT service 

4 technician to service and repair CRT 

5 items that— 

6 ‘‘(aa) are furnished by such 

7 supplier; and 

8 ‘‘(bb) at the time of the 

9 need for repair, are located in a 

10 service area of the supplier; or 

11 ‘‘(II) if the qualified individual 

12 lives outside the service area served by 

13 such supplier at the time of order of 

14 the CRT item, the supplier shall dis15 close in writing to the qualified indi16 vidual that the supplier does not pro17 vide repair service for such item and 

18 provide contact information for enti19 ties that do provide such repair serv20 ice. 

21 ‘‘(vi) RENTAL EQUIPMENT.—If pay22 ment is allowed under paragraph (6), the 

23 supplier of the CRT item provides tem24 porary rental equipment to the qualified 

25 individual when the supplier is repairing a 


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1 qualified individual’s CRT item that was 

2 paid for under this subsection. 

3 ‘‘(4) APPLICATION OF STANDARDS AND AC4 CREDITATION PROGRAM FOR SUPPLIERS OF CRT

5 ITEMS.— 

6 ‘‘(A) IN GENERAL.— 

7 ‘‘(i) REQUIREMENT FOR PROVIDER OR

8 SUPPLIER NUMBER.—The Secretary shall 

9 not provide a supplier of CRT items with 

10 a provider or supplier number to submit 

11 claims for payment under this title unless 

12 the supplier is in compliance with the 

13 standards under paragraph (3). 

14 ‘‘(ii) REQUIREMENT FOR PAYMENT.— 

15 Payment shall not be made under this part 

16 for CRT items furnished by a supplier un17 less the supplier is in compliance with the 

18 standards under paragraph (3). 

19 ‘‘(B) APPLICATION OF ACCREDITATION RE20 QUIREMENT.—In implementing quality stand21 ards under paragraph (3), the Secretary shall 

22 require suppliers furnishing CRT items, on or 

23 after one year after the standards are published 

24 under such paragraph, directly or as a subcon25 tractor for another entity— 


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1 ‘‘(i) to comply with such standards; 

2 and 

3 ‘‘(ii) to have submitted to the Sec4 retary evidence of accreditation by an ac5 creditation organization designated under 

6 subparagraph (C) demonstrating that the 

7 supplier is complying with such standards. 

8 ‘‘(C) DESIGNATION OF INDEPENDENT AC9 CREDITATION ORGANIZATIONS.—Not later than 

10 the date that is one year after the date on 

11 which the Secretary implements the quality 

12 standards under paragraph (3), the Secretary 

13 shall designate and approve one or more inde14 pendent accreditation organizations that— 

15 ‘‘(i) are approved under subsection 

16 (a)(20)(B); and 

17 ‘‘(ii) the Secretary has determined 

18 have the capability to assess whether sup19 pliers of CRT items meet the quality 

20 standards established under paragraph (3). 

21 ‘‘(5) CODING SYSTEM FOR COMPLEX REHABILI22 TATION TECHNOLOGIES.— 

23 ‘‘(A) IN GENERAL.—The Secretary shall, 

24 in consultation with suppliers and manufactur25 ers of CRT items, establish a formal process to 


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1 allow submission of CRT code set modification 

2 requests by stakeholder groups for comprehen3 sive coding changes related to entire policy 

4 groups. This process shall include a specific ap5 plication, public meeting participation and an 

6 appeals process. The Secretary shall then, in 

7 consultation with suppliers and manufacturers 

8 of CRT items, establish a HCPCS coding sub9 set that shall utilize and include HCPCS codes 

10 described in section 1861(iii)(2) for CRT items 

11 for which payment may be made under this 

12 subsection. 

13 ‘‘(B) TREATMENT OF EXISTING PROD14 UCTS.— 

15 ‘‘(i) IN GENERAL.—With respect to 

16 CRT items for which payment was avail17 able under this title before the effective 

18 date of the amendments made by the En19 suring Access to Quality Complex Rehabili20 tation Technology Act of 2015, the Sec21 retary shall assign such items to a code in 

22 the coding subset established under sub23 paragraph (A). 

24 ‘‘(ii) UPDATES.—After the initial as25 signment under clause (i), the Secretary 


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1 may decide to reassign additional product 

2 categories, or items within those cat3 egories, that exist before the date of the 

4 enactment of this subsection to the CRT 

5 coding subset. 

6 ‘‘(iii) CONSULTATION.—Before mak7 ing reassignments of CRT items under 

8 clause (ii), the Secretary shall consult with 

9 suppliers and manufacturers of such items. 

10 The Secretary shall not require manufac11 turers of CRT items for which payment 

12 was available under this title before the ef13 fective date of the amendments made by 

14 the Ensuring Access to Quality Complex 

15 Rehabilitation Technology Act of 2015 to 

16 submit requests for reassignment of the 

17 code for such product to the coding subset 

18 under subparagraph (A) as long as— 

19 ‘‘(I) no changes have been made 

20 to the code definitions, required code 

21 characteristics or test requirements; 

22 and 

23 ‘‘(II) the item was previously 

24 verified to meet the code require25 ments. 


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1 ‘‘(C) REMOVING COMPLEX REHABILITA2 TION TECHNOLOGY FROM DME CODES.—The 

3 Secretary shall, in consultation with suppliers 

4 and manufacturers of CRT items— 

5 ‘‘(i) remove from the coding subset for 

6 durable medical equipment any CRT items 

7 that are included in the coding subset 

8 under subparagraph (A); and 

9 ‘‘(ii) assign new codes to such CRT 

10 items based on technological differences to 

11 support adequate access to meet clinical 

12 outcomes and for purposes of including 

13 such items in the subset under subpara14 graph (A). 

15 ‘‘(D) NEW TECHNOLOGY.— 

16 ‘‘(i) IN GENERAL.—The Secretary 

17 shall update as needed the HCPCS level II 

18 process used to modify the code set to in19 clude CRT items for the purposes of estab20 lishing new codes and determining prod21 ucts to be classified as CRT items. In de22 termining if a product is a CRT item, the 

23 Secretary shall consider— 

24 ‘‘(I) if the product is novel; 


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1 ‘‘(II) the clinical application of 

2 the product; and 

3 ‘‘(III) the ability of the product 

4 to address the unique needs and ca5 pacities of a qualified individual. 

6 ‘‘(ii) INCLUSION OF CODES IN LIST.— 

7 The Secretary shall include the codes es8 tablished in clause (i) in the list under sec9 tion 1861(iii)(2)(F). 

10 ‘‘(E) MISCELLANEOUS CODE FOR INNOVA11 TION AND LOCAL COVERAGE DETERMINA12 TIONS.—The coding subset established under 

13 subparagraph (A) shall include at least one mis14 cellaneous code for items not otherwise classi15 fied. 

16 ‘‘(F) ESTABLISHMENT OF ADEQUATE

17 HCPCS CODES TO REFLECT SPECIALIZED NA18 TURE OF CRT.—The Secretary shall ensure that 

19 HCPCS codes exist (or are developed) to rep20 resent the specialized nature of CRT, including 

21 codes to represent custom CRT manual and 

22 power wheelchairs and modifications to CRT 

23 manual and power wheelchair frames, and mis24 cellaneous codes for CRT manual and power 

25 wheelchairs that are otherwise classified. 


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1 ‘‘(6) REPLACEMENT OF CRT ITEMS.— 

2 ‘‘(A) IN GENERAL.—Payment shall be 

3 made for the replacement of a CRT item (or for 

4 the replacement of any part of such item) with5 out regard to continuous use or useful lifetime 

6 restrictions established under section 

7 1834(a)(7)(C) for items of durable medical 

8 equipment if a qualified ordering practitioner 

9 determines that the provision of a replacement 

10 item (or a replacement part of such an item) is 

11 necessary because— 

12 ‘‘(i) there was a change in the physio13 logical condition of the qualified individual 

14 to whom such item was provided; 

15 ‘‘(ii) there was an irreparable change 

16 in the condition of the CRT item (or, in 

17 the case of the replacement of a part, in 

18 the part of the CRT item); or 

19 ‘‘(iii) the CRT item requires repairs 

20 and the cost of such repairs would be more 

21 than 50 percent of the cost of a replace22 ment of the CRT item. 

23 ‘‘(B) DEFERRAL TO PROVIDERS.— 

24 ‘‘(i) IN GENERAL.—Subject to clause 

25 (ii), if a qualified ordering practitioner deVerDate Sep 11 2014 00:27 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\S1013.IS S1013

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1 termines that a replacement of the CRT 

2 item, or the replacement of a part of a 

3 CRT item, is necessary pursuant to sub4 paragraph (A), the replacement item or 

5 part is deemed to be reasonable and nec6 essary for purposes of section 

7 1862(a)(1)(A). 

8 ‘‘(ii) EXCEPTION FOR ITEMS UNDER 3

9 YEARS OLD.—If the CRT item that is 

10 being replaced (or the part of the CRT 

11 item that is being replaced) under subpara12 graph (A) is less than 3 years old (cal13 culated from the date on which the quali14 fied individual began to use the CRT item 

15 or part), the Secretary may require the 

16 qualified ordering practitioner to provide 

17 confirmation of necessity of the replace18 ment item or replacement part, as the case 

19 may be. 

20 ‘‘(7) PAYMENT FOR TEMPORARY RENTAL.— 

21 ‘‘(A) IN GENERAL.—If a CRT item owned 

22 by a qualified individual needs to be repaired, 

23 payment may be made under this subsection for 

24 the temporary rental of a CRT item while the 


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1 CRT item owned by such individual is being re2 paired. 

3 ‘‘(B) BASIS; LIMITATION.—Payment per4 mitted under subparagraph (A) shall be made 

5 on a monthly basis, and the period of rental 

6 may not exceed two months. 

7 ‘‘(C) PAYMENT AMOUNT.—The amount of 

8 payment allowed under subparagraph (A) for a 

9 month for the rental of a CRT item shall be 10 

10 percent of the purchase price for the CRT item. 

11 ‘‘(8) DEFINITIONS.—For purposes of this sub12 section: 

13 ‘‘(A) HCPCS.—The term ‘HCPCS’ refers 

14 to the Health Care Procedure Coding System. 

15 ‘‘(B) QUALIFIED CRT PROFESSIONAL.— 

16 ‘‘(i) IN GENERAL.—The term ‘quali17 fied CRT professional’ means an individual 

18 who— 

19 ‘‘(I) is certified by the Rehabili20 tation Engineering and Assistive 

21 Technology Society of North America 

22 as an assistive technology professional 

23 or is certified by another organization 

24 designated by the Secretary (acting in 

25 consultation with relevant parties) as 


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1 providing a certification that is equiv2 alent to, or more stringent than, the 

3 assistive technology professional cer4 tification; and 

5 ‘‘(II) beginning two years after 

6 the establishment of the designation 

7 under clause (ii), achieves an addi8 tional designation that demonstrates 

9 the individual’s competencies and ex10 perience in supplying CRT items. 

11 ‘‘(ii) ESTABLISHMENT.—Not later 

12 than one year after the date of the enact13 ment of this subsection, the Secretary, act14 ing in consultation with relevant parties, 

15 shall establish the additional designation 

16 under clause (i)(II). 

17 ‘‘(iii) RELEVANT PARTIES.—For pur18 poses of this subparagraph, the term ‘rel19 evant parties’ includes clinicians, consumer 

20 groups, CRT suppliers, and CRT manufac21 turers. 

22 ‘‘(C) QUALIFIED CRT SERVICE TECHNI23 CIAN.—The term ‘qualified CRT service techni24 cian’ means an individual who— 


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1 ‘‘(i) is factory-trained by the manufac2 turers of the CRT items being offered by 

3 the suppler of such items; 

4 ‘‘(ii) is trained and educated (includ5 ing through on-the-job training) to assem6 ble, fit, program, service, and repair CRT 

7 items; and 

8 ‘‘(iii) on an annual basis, completes at 

9 least 10 hours of continuing education spe10 cific to the assembly, fitting, programming, 

11 service, and repair of CRT items. 

12 ‘‘(D) QUALIFIED INDIVIDUAL.—The term 

13 ‘qualified individual’ has the meaning given 

14 such term in section 1861(iii)(3)(E). 

15 ‘‘(E) QUALIFIED ORDERING PRACTI16 TIONER.—The term ‘qualified ordering practi17 tioner’ means a physician (as defined in section 

18 1861(r)), a physician assistant, nurse practi19 tioner, or a clinical nurse specialist (as those 

20 terms are defined in section 1861(aa)(5)). 

21 ‘‘(F) QUALIFIED LICENSED CLINICIAN.— 

22 The term ‘qualified licensed clinician’ means a 

23 licensed physical therapist or occupational ther24 apist or physician who possesses specialized 

25 training and experience in providing seating 


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1 and mobility services and the skills to perform 

2 all aspects of the evaluation described in para3 graph (2)(B)(i)(II).’’. 

4 SEC. 5. CONFORMING AMENDMENTS. 

5 (a) EXCLUSION FROM THE IN-HOME USE LIMITA6 TION FOR DME.—Section 1861(n) of the Social Security 

7 Act (42 U.S.C. 1395x(n)) is amended by adding at the 

8 end the following: ‘‘For 2016 and subsequent years, such 

9 term does not include complex rehabilitation technologies 

10 (as defined in subsection (iii)).’’. 

11 (b) EXEMPTION FROM COMPETITIVE ACQUISI12 TION.—Section 1847(a)(7) of the Social Security Act (42 

13 U.S.C. 1395w–3(a)(7)) is amended by adding at the end 

14 the following new subparagraph: 

15 ‘‘(C) CRT ITEMS.—For 2016 and subse16 quent years, complex rehabilitation technology 

17 items (as defined in section 1861(iii)).’’. 

18 (c) EXEMPTION FROM SNF CONSOLIDATED BILL19 ING.—Section 1888(e)(2)(A)(iii) of the Social Security Act 

20 (42 U.S.C. 1395yy(e)(2)(A)(iii)) is amended by adding at 

21 the end the following: 

22 ‘‘(VI) Complex rehabilitation 

23 technology items (as defined in section 

24 1861(iii)) if delivered to an inpatient 

25 for use during the stay in the skilled 


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1 nursing facility as part of the plan of 

2 care to allow the transition of such 

3 qualified individuals from the skilled 

4 nursing facility setting to the home 

5 and community.’’. 

6 (d) PAYMENT EXCLUSIONS.—Section 1834(a) of the 

7 Social Security Act (42 U.S.C. 1395m(a)) is amended— 

8 (1) in paragraph (4), by adding at the end the 

9 following sentence ‘‘For 2016 and subsequent years, 

10 the items covered by this paragraph shall not include 

11 complex rehabilitation technology items (as defined 

12 in section 1861(iii)).’’; 

13 (2) in paragraph (7)(A), by adding at the end 

14 the following: ‘‘For fiscal year 2016 and subsequent 

15 years, the previous sentence shall not apply to 

16 power-driven wheelchairs that are designated as 

17 CRT items under section 1861(iii).’’; and 

18 (3) in paragraph (16), by inserting at the end 

19 the following: ‘‘The Secretary shall impose (and, 

20 may, as allowed by the second sentence of this para21 graph, waive) the requirements of the first sentence 

22 of this paragraph to suppliers of complex rehabilita23 tion technology items, except that, in order to avoid 

24 duplicate bonds, the Secretary shall not impose such 

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1 habilitation technology items if such suppliers also 

2 participate in the Medicare program as suppliers of 

3 durable medical equipment.’’. 

4 (e) REQUIREMENTS FOR SUPPLIERS OF MEDICAL

5 EQUIPMENT AND SUPPLIES.—Section 1834(j)(5) of the 

6 Social Security Act (42 U.S.C. 1395m(j)(5)) is amend7 ed— 

8 (1) by redesignating subparagraphs (E) and 

9 (F) as subparagraphs (F) and (G), respectively; 

10 (2) by inserting after subparagraph (D) the fol11 lowing new subparagraph: 

12 ‘‘(E) complex rehabilitation technology 

13 items (as defined in section 1861(iii));’’. 

14 SEC. 6. EFFECTIVE DATE. 

15 The amendments made by this Act shall apply to 

16 items and services furnished on or after January 1, 2016. 

Æ 


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